Representatives across both sides of the aisle have expressed enthusiasm for the bill over the last two days, particularly for the additional funding -- $1.75bn per year for five years for the NIH (National Institutes of Health) and $110m per year for five years for the FDA.
However, the White House claims that the FDA will have some difficulties completing all of the new work as laid out in the bill. The “new responsibilities for FDA outlined in H.R. 6 exceed the resources provided in the bill and the President’s FY 2016 Budget and as such, FDA will be unable to fully implement the programs established in the bill, while maintaining its current performance levels,” the White House said.
Mandatory v. Discretionary
Another major sticking point with 21st Century Cures right now is whether that funding will be discretionary or mandatory. The House Rules Committee on Wednesday voted to approve an amendment from Rep. David Brat (R-VA) that would make the funding discretionary, which means it would have to be set on an annual basis by Congress.
Neil Bradley, Chief Strategy Officer of the Conservative Reform Network and former Hill leadership staff, explained why the funding in the bill should be mandatory, noting, “Conservatives would be rightly concerned if the mandatory spending proposed in 21st Century Cures was for an indefinite amount or was not sunset. In which case, it would look like the runaway mandatory spending fiscal conservatives fight to restrain. But the mandatory spending proposed in 21st Century Cures is capped by the amount provided and is sunset.”
The switch to discretionary spending may cause some trepidation in the House, especially as legislators are looking to pay for the bill largely through the sale of 64 million barrels of crude oil from the Strategic Petroleum Reserve, which would reduce the size of the reserve by about 10%, according to a Politico op-ed from Larry Goldstein, a trustee at the Energy Policy Research Foundation and Lucian Pugliaresi, president of the foundation.
On the oil reserve front, the Administration said it “reiterates the critical importance of making the investments necessary to modernize the Strategic Petroleum Reserve and ensure it continues to support US energy security.”
Additional concerns from the White House include the bill’s extending drug exclusivity beyond current law, and how this will affect drug costs, and that the bill “would make funding subject to problematic ideological riders included in appropriations bills,” including an anti-abortion rider that Democrat representatives highlighted in discussions on the House floor Thursday.
The White House also said the bill “could undermine regulatory standards by allowing unproven uses of therapies to be marketed to health care payors as though such uses had been proven safe and effective.”
Two medicine professors from Harvard University recently raised similar questions over whether the bill might give the FDA too much discretion in approving new drugs and devices without conventional clinical trials.
Despite the question marks, House Speaker John Boehner (R-OH), as well as bill co-sponsors Fred Upton (R-MI) and Diana DeGette (D-CO) and industry group PhRMA seem to be anticipating a vote of approval from the full House on Friday.